Events

Recall of QUICK-CROSS EXTREME SUPPORT CATHETER (STRAIGHT TIP BRAIDED)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SPECTRANETICS CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    110275
  • Event Risk Class
    III
  • Event Initiated Date
    2016-03-31
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    All shipments since july 2014 containing affected products are suspect of not having instructions for use (ifu) with the product package.

Device

QUICK-CROSS EXTREME SUPPORT CATHETER (STRAIGHT TIP BRAIDED)
  • Model / Serial
    Model Catalog: 518-076 (Lot serial: FAB15F04A); Model Catalog: 518-035 (Lot serial: FQQ15M03A); Model Catalog: 518-033 (Lot serial: FQQ15M03A); Model Catalog: 518-065 (Lot serial: FQP15M01A); Model Catalog: 518-038 (Lot serial: FQP15M01A); Model Catalog: 518-037 (Lot serial: FQP15M01A); Model Catalog: 518-036 (Lot serial: FQP15M01A); Model Catalog: 518-035 (Lot serial: FQP15M01A); Model Catalog: 518-033 (Lot serial: FQP15M01A); Model Catalog: 518-065 (Lot serial: FQN15L25A); Model Catalog: 518-038 (Lot serial: FQN15L25A); Model Catalog: 518-037 (Lot serial: FQN15L25A); Model Catalog: 518-036 (Lot serial: FQN15L25A); Model Catalog: 518-035 (Lot serial: FQN15L25A); Model Catalog: 518-033 (Lot serial: FQN15L25A); Model Catalog: 518-065 (Lot serial: FQL15L09A); Model Catalog: 518-038 (Lot serial: FQL15L09A); Model Catalog: 518-037 (Lot serial: FQL15L09A); Model Catalog: 518-036 (Lot serial: FQL15L09A); Model Catalog: 518-035 (Lot serial: FQL15L09A); Model Catalog: 518-033 (Lot serial: FQL15L09A); Model Catalog:
  • Product Description
    QUICK-CROSS EXTREME SUPPORT CATHETER;QUICK-CROSS SUPPORT CATHETER;QUICK-CROSS SELECT SUPPORT CATHETER;QUICKCAT EXTRACTION CATHETER
  • Manufacturer
    SPECTRANETICS CORPORATION

Manufacturer

SPECTRANETICS CORPORATION
  • Manufacturer Address
    COLORADO SPRINGS
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC